• Nazanin Alavi, Megan Yang, Callum Stephenson, Niloofar Nikjoo, Niloufar Malakouti, Gina Layzell, Jasleen Jagayat, Amirhossein Shirazi, Dianne Groll, Mohsen Omrani, Anne O'Riordan, Sarosh Khalid-Khan, Rafael Freire, Elisa Brietzke, Fabiano Alves Gomes, Roumen Milev, and Claudio N Soares.
• Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.
• JMIR Res Protoc. 2020 Dec 18; 9 (12): e24913.

BackgroundThe considerable rise of mental health challenges during the COVID-19 pandemic has had detrimental effects on the public health sector and economy. To meet the overwhelming and growing demand for mental health care, innovative approaches must be employed to significantly expand mental health care delivery capacity. Although it is not feasible to increase the number of mental health care providers or hours they work in the short term, improving their time efficiency may be a viable solution. Virtually and digitally delivering psychotherapy, which has been shown to be efficient and clinically effective, might be a good method for addressing this growing demand.ObjectiveThis research protocol aims to evaluate the feasibility and efficacy of using an online, digital, asynchronous care model to treat mental health issues that are started or aggravated by stressors associated with the COVID-19 pandemic.MethodsThis nonrandomized controlled trial intervention will be delivered through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants will be offered a 9-week electronically delivered cognitive behavioral therapy program that is tailored to address mental health problems in the context of the COVID-19 pandemic. This program will involve weekly self-guided educational material that provides an overview of behavioral skills and weekly homework. Participants (N=80) will receive personalized feedback from and weekly interaction with a therapist throughout the course of the program. The efficacy of the program will be evaluated using clinically validated symptomology questionnaires, which are to be completed by participants at baseline, week 5, and posttreatment. Inclusion criteria includes the capacity to consent; a primary diagnosis of generalized anxiety disorder or major depressive disorder, with symptoms that started or worsened during the COVID-19 pandemic; the ability to speak and read English; and consistent and reliable access to the internet. Exclusion criteria includes active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation.ResultsThis study received funding in May 2020. Ethics approval was received in June 2020. The recruitment of participants began in June 2020. Participant recruitment is being conducted via social media, web-based communities, and physician referrals. To date, 58 participants have been recruited (intervention group: n=35; control group: n=23). Data collection is expected to conclude by the end of 2020. Analyses (ie, linear regression analysis for continuous outcomes and binomial regression analysis for categorical outcomes) are expected to be completed by February 2021.ConclusionsIf proven feasible, this care delivery method could increase care capacity by up to fourfold. The findings from this study can potentially influence clinical practices and policies and increase accessibility to care during the COVID-19 pandemic, without sacrificing the quality of care.Trial RegistrationClinicalTrials.gov NCT04476667; https://clinicaltrials.gov/ct2/show/NCT04476667.International Registered Report Identifier (Irrid)DERR1-10.2196/24913.©Nazanin Alavi, Megan Yang, Callum Stephenson, Niloofar Nikjoo, Niloufar Malakouti, Gina Layzell, Jasleen Jagayat, Amirhossein Shirazi, Dianne Groll, Mohsen Omrani, Anne O'Riordan, Sarosh Khalid-Khan, Rafael Freire, Elisa Brietzke, Fabiano Alves Gomes, Roumen Milev, Claudio N Soares. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.12.2020.

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